Hysterectomies have traditionally been performed by making a cut through the abdomen wall, freeing up the uterus and removing the uterus through the cut in the wall. In more recent times some hysterectomies have been able to be performed through the vaginal opening which consists in freeing up the uterus by using laparoscopic instruments and then removing the uterus through an opening made at the top of the vagina.
Laparoscopic procedures require the abdomen to be inflated with gas, to form a pneumoperitoneum, which enables the surgeon to see what needs to be done and easily move the instruments around and position them to make the necessary cuts, sutures etc. Thus laparoscopically assisted vaginal hysterectomy (LAVH) is considered an advanced laparoscopic operative procedure.
One difficulty with LAVH procedures is that once the cut is made at the top of the vagina in order to allow the uterus to be removed, the gas in the abdomen escapes, making it difficult and time consuming to finally release the uterus from the abdomen (cut ligaments etc) and remove it through the vaginal opening. Therefore, although LAVH allows patients to avoid undergoing abdomen hysterectomy procedures, thus affording them a more rapid recovery, the vaginal portion of the operation can still be extremely difficult if there is little descent of the cervix, especially when the uterus is very large. In such instances the vaginal portion of the surgery can take almost as long as the laparoscopic portion and can cause great stress to the surgeon and lead to significant blood loss. The more dissection performed laparoscopically, the easier the vaginal component of the surgery. Therefore, the longer the pneumoperitoneum can be maintained the more efficient the procedure becomes. Bleeding and/or damage to the ureter is also a significant problem. Formation of the "bladder flap" can be difficult and hazardous with perforation of the bladder on occasions occurring. However, the bladder has to be disected off the lower segment of the uterus before the uterine arteries can be approached. In an attempt to make the "bladder flap" dissection easier, the initial dissection has been performed vaginally without opening the peritoneal fold of the utero-vesical space. However, if the fold of the peritoneum is breached, then gas can escape from the abdomen into the vagina thus deflating the abdomen and making it impossible to continue the surgery. In order to minimise this problem saline packs have been placed into the vagina in an attempt to slow down gas leak, but rarely does this prove to be satisfactory.
In addition to this, in order for the hysterectomy procedure to be completed efficiently via the laparoscope, it is necessary to manipulate certain organs in order to obtain access to make the necessary cuts, sutures etc. For example, it may be necessary to push the uterus high up into the abdomen to free the ligaments for access by the surgeon.
A further difficulty occurs in forming the pneumoperitoneum as standard techniques usually involve the blind insertion of the gas used via a Verres needle. As this is a blind insertion of the gas, the operator cannot have complete confidence in where the gas is being inserted.
Sabella et al in Obstet. Gynecol. 1996:87:465 entitled "A Technique for Laparoscopic Completion of Vaginal Hysterectomy" disclosed a uterine manipulator including an inflatable cuff that seals the vaginal orifice thus maintaining the pneumoperitoneum.
The technique described by Sabella et al involves proceeding with a vaginal hysterectomy until the opening of the peritoneal reflections and ligature of uterine vessels and uterosacral ligaments. It is at this point, if laparoscopic assistance becomes necessary, that the uterine manipulator with inflatable cuff is inserted vaginally, allowing completion of the operation laparoscopically.
The uterine manipulator described in the Sabella article suffers from a number of deficiencies. Once the cuff is inflated the uterine manipulator is fixed in position. The manipulator can only be restrictively manoevered about that point and cannot readily extend the uterus further into the pelvis. There is no disclosure of any uterine manipulation means able to move independently in relation to the apparatus once the cuff is inflated. The Sabella device therefore, does not make it easy to stretch out the tissue between the cervix and the vagina that it is to be transected with, via stapling device or diathermy for example, while maintaining the pneumoperitoneum. In addition, the surgeon will be operating in close proximity to the inflated cuff increasing the inherent risk of puncture and losing the pneumoperitoneum.
European Patent Application 0642766 to the United States Surgical Corporation discloses a manipulator apparatus for use in hysterectomy procedures that also includes an inflatable member. This apparatus utilises the inflatable member to engage the uterine wall in order to position the uterus for examination purposes. The inflatable member is not used to seal the vaginal orifice and there is no disclosure of any uterine manipulation means able to move independently of the inflatable member.
There is therefore a need for a device capable of maintaining a pneumoperitoneum throughout LAVH procedures. There is also a need for a device which will maintain a pneumoperitoneum together with providing means to manipulate the uterus as may be necessary during the LAVH procedure. There is also a need for a device which can improve the creation of a pneumoperitoneum during LAVH procedures.
The field of surgery is also beginning to utilise mechanical means, such as robotic manipulation, for assisting surgeons in performing surgical procedures. This technology involves the surgeon directing the robotic mechanical manipulation means during the performance of a surgical procedure. In order for hysterectomies and other uterine procedures to be able to utilise this technology, it will be advantageous if not essential to provide a fixed fulcrum point about which and from which the manipulation device can be moved.
It is an object of the invention to go some way to meeting the identified needs or to provide the public with a useful choice.